NCT06207240

Functional Electrical Stimulation Therapy After Stroke

Efficacy and Feasibility of Using the NeuroLife Sleeve System to Improve Hand Function in Stroke Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Battelle Memorial Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this feasibility study is to test the feasibility of providing task-oriented, intention-driven functional electrical stimulation (FES) using the novel NeuroLife FES Sleeve and NeuroLife electromyography (EMG) and FES Sleeve devices in chronic stroke survivors. The main questions it aims to answer are: * Can these devices be used to administer task-oriented therapy with assistive stimulation at similar doses to current standards of care? * How does therapy using these devices impact the upper limb function in a few chronic stroke survivors? Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks.

Detailed description

Battelle has developed the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices, wearable sleeves that deliver non-invasive functional electrical stimulation (FES) paired with user intention. Participants in this study will use these devices while practicing functional tasks for about one hour at each session. FES will be applied through the forearm sleeve devices to assist with hand movements and grasps required by functional tasks simulating everyday activities such as turning a key or picking up a phone. Sessions will be scheduled three days per week for 8 weeks total. Participants will complete clinical assessments at the beginning, midpoint and end of intervention as well as at follow-up sessions 2- and 10-weeks after the end of intervention to track upper limb function and impairment. Each session will last 1.5-2 hours, and participants will be compensated for their time.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve	Electrical stimulation will be delivered via the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices to assist with movement during functional task practice.

Timeline

• Start date: 2022-01-18
• Primary completion: 2022-06-08
• Completion: 2022-06-08
• First posted: 2024-01-16
• Last updated: 2024-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study